EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2 093)AS THERAPY FOR PATIENTS WITH POST-HERPETIC NEURALGIA:A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIA

• Conditions: adult patients with post-herpetic neuralgia; MedDRA version: 9.1Level: PTClassification code 10036376Term: Post herpetic neuralgia

• Registration Number: EUCTR2007-002473-31-BG
• Lead Sponsor: BIAL - Portela & Ca, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Inclusion criteria at screening:
• Written informed consent to participate in the study
• Men and women aged 18 years or older
• Previous diagnosis of herpes zoster
• Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
•Cooperation and willingness to complete all aspects of the study

Inclusion criteria at randomisation:
• Completion of at least 4 daily diaries during the week preceding randomisation
• A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
• Active herpes zoster lesion or dermatitis of any origin at the affected site
• Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
• Significant or unstable medical or psychiatric disorders
• Drug or alcohol abuse in the preceding 2 years
• Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
• Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
• Previous participation in any study with eslicarbazepine acetate
• Pregnancy or breast feeding
• History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
• History of non-compliance
• Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
• Participation in a clinical study within 3 months prior to screening
• Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified